Today, BioVaxys (CSE: BIOV, FRA:5LB, OTCQB:BVAXF) announced that it has completed a pivotal study on its experimental COVID vaccine, BVX-0320, that supports the vaccine’s improved safety profile compared to the available mRNA vaccines (Pfizer, Moderna). The company conducted an experiment to determine whether BVX-0320, a haptenized version of the SARS-CoV-2 spike protein, binds to the Angiotensin Converting Enzyme-2 (ACE2) receptor found on many types of human cells (including lung, heart, and blood cell types). The medical community has already established the dangerous consequences this spike protein – ACE2 receptor interaction, which can result in life threatening conditions such as myocarditis and deep vein thrombosis. These ailments, along with pericarditis and myocardial infarction (heart attack) have presented as adverse effects in patient subpopulations after mRNA vaccination. This key finding adds to the growing set of data that suggests that BioVaxys’ BVX-0320 could be a potent inhibitor of SARS-CoV-2 infection that delivers efficacy without the safety concerns that plague currently available vaccines.
The ongoing emergence of new variants is unlikely to end any time soon, forcing vaccine developers to play a game in which they are always a day late and a dollar short. A significant portion of the global population is wary of taking experimental drugs that have been accelerated through the regulatory process, and the idea of a never-ending cycle of “boosters” is abhorrent to those who are skeptical about government and Big Pharma’s motives. But what if a universal, “pan-sarbecovirus” vaccine was developed that eliminated the life-threatening adverse conditions (such as heart inflammation and abnormal blood clotting) and provided a robust, durable immunity against all future SRS-CoV-2 variants? This is the Holy Grail of vaccine development, and BioVaxys just might hold the map.
The core of BioVaxy’s innovation is the attachment of a “hapten” protein to their s-protein vaccine. Haptens are molecules that induce an immune response only when attached to a large carrier protein, such as BioVaxy’s engineered s-protein, and can increase the targeted immune response. This small biochemical modification not only increases the efficacy of the haptenized vaccine, but affects the duration of immune protection and may also play a role in reducing deleterious side effects. These three key improvements of BioVaxy’s BVX-0320 hapten technology are discussed below.
Preclinical studies of BVX-0320, Biovaxys’ haptenized s-protein conjugate vaccine, in mice demonstrated a 96.4% positive response (as measured by the production of spike protein-specific antibodies six weeks post-vaccination). None of the mice experienced toxicities and the vaccine demonstrated an excellent safety profile. The final result of this preclinical study concluded that a 10ug (ten microgram) dose of BVX-0320 (2-dose regimen), produced an antibody titer of 1:9430, which is ~2.5x greater than the antibody response elicited by the standard 50ug (2-dose regimen) of Moderna’s mRNA-1273 and over 6.5x greater than that of Pfizer’s BNT162b2. This implies that, on a gram-for-gram basis, BVX-0320 is 12-33x more effective at inducing antibody production against the spike protein.
In collaboration with The Ohio State University, BioVaxys analyzed the blood sera taken from mice previously vaccinated with BVX-0320 for the presence of neutralizing antibodies. Neutralizing antibodies directed against the virus’s s-protein prevent the binding of the s-protein to the human ACE2 receptor (found on multiple cell types, not limited to lung, heart, and blood cells). The company found that BVX-0320 elicits a neutralizing antibody response against SARS-CoV-2. Although these results strongly suggest that BVX-0320 is a viable vaccine candidate, BioVaxys President and COO believes that the superiority of BVX-0320 over the mRNA vaccines lies in its ability to evoke a strong “T-Cell” response:
"Although we're pleased to see a reduction in plaques as measured by the Plaque Reduction Neutralization Test, it's our belief that a robust T-cell response is key for eliciting a long-term immune protection. As its not fully known yet whether the durability of the antibodies induced by SARS-CoV-2 or the antibody titres will protect against reinfection, the induction of SARS-CoV-2-specific memory T-cells and B cells (as opposed to circulating antibodies) is important for long-term protection."
BioVaxys also conducted experiments to quantify BVX-0320’s impact on eliciting a durable, long-lasting immunity through T-cell activation (Learn more about the basics of antibodies, T-cells, and the immune response to viral infection). Further analysis of their preclinical mouse study revealed that a 10ug dose of the haptenized viral s-protein elicited a robust T-cell response against SARS-CoV-2. T-cells are a component of the cellular immune system and remain active against pathogens once antibodies are no longer present. For some inexplicable reason, Big Pharma has paid no attention to their vaccine’s effects on T-cell activity, instead focusing all of their efforts on quantifying neutralizing antibody activity (although, to the credit of the greater research community, some academic institutions have explored T-cell responses to mRNA vaccines on their own). In its totality, BioVaxys’ preclinical studies in mice conclusively show that BVX-0320 elicits a strong, diverse immune response by inducing neutralizing antibodies against the virus’s s-protein that prevent viral infection of host human cells and activating cytotoxic T-cells that have the capability to kill host human cells infected by the virus. These results are succinctly encapsulated in Ken Kovan’s comment:
"This is an exciting development not only in the COVID-19 vaccine field, but potentially for other viral vaccines. Post-vaccination generation of antibodies is no doubt critical and garners much attention. However, antibody levels can quickly become undetectable after just a few months, leading to the conclusion that anti-viral immunity has waned." He goes on to say that "a robust CD4 and CD8 T-cell response, such as that we are seeing, has potential to confer much longer protection."
Currently, available vaccines deliver a portion of the SARS-CoV-2 spike protein, which can result in rare, but life-threatening side effects. In a peer-reviewed paper published in the Journal of Hematological Oncology, researchers discovered that the SARS-CoV-2 spike protein binds to the ACE2 receptor found on human cells, resulting in adverse effects such as abnormal blood clotting and myocarditis. Biovaxys suspected that haptenizing the spike protein may interfere with its binding to the ACE2 receptor. Today, the company announced the completion of study that showed that BVX-0320 does not bind to the ACE2 receptor, suggesting that their vaccine may not lead to the serious side effects associated with the available mRNA vaccines. This study was conducted by Millipore-Sigma, a CDMO that has been contracted by BioVaxys to produce more BVX-0320 for the company’s ongoing collaboration with The Ohio State University to create a universal pan-sarbecovirus vaccine platform. Read the press release here.
As the pandemic continues to develop, the SARS variants are developing ever increasing numbers of mutations in key regions of their genetic code that allow them to evade immune detection and render available vaccines impotent. The number of mutations and diversity of mutation sites makes it increasingly more difficult to predict what the next novel variant will look like and develop a vaccine against it. A more robust approach is needed that is agnostic to future variant designs. BioVaxys believes that they hold the key to developing a universal, “pan-sarbecovirus” vaccine, and have entered into a partnership with The Ohio State University to pursue this endeavor. Their theory is that previous infection with the SARS-CoV-1 variant predicts a stronger neutralizing antibody response to subsequent vaccination with a SARS-CoV-2 vaccine. The goal of the partnership is to “stimulate virus cross-reactivity and induce immunity against all or most SARS viruses by immunizing people who have convalesced from a documented COVID-19 infection or received a full course of any COVID-19 vaccine, leading to a pan-sarbecovirus vaccine that encompasses current and emerging SARS-CoV-2 variants.”
The biotech sector has been beaten to a pulp in the last year with the XBI Biotech ETF down more than 40%. The magnitude of the decline means that the biotech sector is officially in the midst of a bear market. Bear markets are challenging because most share prices will continue to fall and remain in pronounced downtrends. However, bear markets don’t last forever and the ashes of the bear market eventually provides fertile soil for the next bull market. Bear markets also offer abundant opportunity for savvy investors who are able to sift through the rubble and uncover diamonds hiding in plain sight.
The key is to stay in the game and to wait for A+ setups. Do not allow impatience or stubbornness to lead to poor decision making in the market. We should invest 90% of our time and energy conducting the research that is required to uncover the best opportunities. Then we should use technical analysis to help guide our market timing decisions. We should also remove FOMO (fear of missing out) from our consciousness by acknowledging that we will never buy the EXACT bottom. Therefore, it makes the most sense to scale into positions gradually over time by buying in three or four tranches - there should not be a hurry to accumulate a full-sized position until there is strong evidence that a major bottom is in place.
Biovaxys shares have been mired in a downtrend since peaking near $.60 last September, and in the last few weeks BIOV reached a new all-time low at $.155:
A strong move back above $.21 (orange dotted line) would create a potential failed breakdown setup where the recent lows could prove to be a capitulation flush. However, for a new uptrend to be confirmed we will need to see a daily close above $.28 (purple dotted line). The BIOV daily chart is exhibiting characteristics of a stock that is not only oversold, but in which sellers are exhausted (relatively low volume and waning selling pressure in recent weeks). Once a catalyst emerges that creates strong buying pressure we could see BIOV’s share price double in a very short period of time.
Author owns BIOV.CA shares at the time of publishing and may choose to buy or sell at any time without notice. Author has been compensated for marketing services by BioVaxys Technology Corp.
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